Trial Outcomes & Findings for Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma (NCT NCT01169337)

NCT ID: NCT01169337

Last Updated: 2025-11-10

Results Overview

Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE3
• Target enrollment: 226 participants
• Primary outcome timeframe: Assessed every 4 weeks while on treatment up to 24 weeks
• Results posted on: 2025-11-10

Participant Flow

Between January 2011 and January 2013, 44 patients were enrolled in the phase II safety run in portion of the study and were treated with lenalidomide as a single agent. Between February 2013 and July 2017, 182 patients were randomly assigned between the two treatment arms in the phase III portion of the study.

Participant milestones

Measure	Arm A (Lenalidomide; Phase II) Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Lenalidomide; Phase III) Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) Patients undergo observation until progression to symptomatic myeloma.
Overall Study STARTED	44	90	92
Overall Study Received Treatment/Observation	44	88	86
Overall Study COMPLETED	0	0	86
Overall Study NOT COMPLETED	44	90	6

Reasons for withdrawal

Measure	Arm A (Lenalidomide; Phase II) Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Lenalidomide; Phase III) Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) Patients undergo observation until progression to symptomatic myeloma.
Overall Study Lack of Efficacy	5	7	0
Overall Study Adverse Event	12	18	0
Overall Study Death	2	0	0
Overall Study Withdrawal by Subject	11	11	6
Overall Study Noncompliance	2	0	0
Overall Study Other complicating disease	1	1	0
Overall Study Physician Decision	1	5	0
Overall Study Alternative therapy	0	2	0
Overall Study Changed hospital	0	1	0
Overall Study Never started treatment	0	2	0
Overall Study Reason not reported	1	0	0
Overall Study Continuing lenalidomide	9	43	0

Baseline Characteristics

Lenalidomide or Observation in Treating Patients With Asymptomatic High-Risk Smoldering Multiple Myeloma

Baseline characteristics by cohort

Measure	Arm A (Lenalidomide; Phase II) n=44 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Lenalidomide; Phase III) n=90 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=92 Participants Patients undergo observation until progression to symptomatic myeloma.	Total n=226 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	63 years n=20 Participants	64 years n=40 Participants	64 years n=28 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	48 Participants n=20 Participants	46 Participants n=40 Participants	118 Participants n=28 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	42 Participants n=20 Participants	46 Participants n=40 Participants	108 Participants n=28 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=20 Participants	4 Participants n=40 Participants	6 Participants n=28 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	81 Participants n=20 Participants	81 Participants n=40 Participants	205 Participants n=28 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	7 Participants n=20 Participants	7 Participants n=40 Participants	15 Participants n=28 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=20 Participants	1 Participants n=40 Participants	2 Participants n=28 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	12 Participants n=20 Participants	19 Participants n=40 Participants	37 Participants n=28 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants	72 Participants n=20 Participants	68 Participants n=40 Participants	177 Participants n=28 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=20 Participants	0 Participants n=40 Participants	0 Participants n=28 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	5 Participants n=20 Participants	4 Participants n=40 Participants	10 Participants n=28 Participants

PRIMARY outcome

Timeframe: Assessed every 4 weeks while on treatment up to 24 weeks

Population: The first 36 patients in the phase II part as planned in the study design

Proportion of patients with grade 3 adverse events that effect vital organ function (such as cardiac, hepatic or thromboembolic) or any grade 4 or higher non-hematologic adverse events

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=36 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) Patients undergo observation until progression to symptomatic myeloma.
Proportion of Patients With Grade 3 Adverse Events That Effect Vital Organ Function or Any Grade 4 or Higher Non-hematologic Adverse Events (Phase II Primary Endpoint)	0.056 proportion of participants Interval 0.01 to 0.165	—

PRIMARY outcome

Timeframe: Assessed every 3 months for 2 years

Population: All randomized patients

PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year PFS rate.

1. Any of the following:

• Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression"
• Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression"
• Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)

2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder:

• Hypercalcemia (> 11 mg/dL)
• Decrease in hemoglobin of ≥ 2 gms/dL
• Serum creatinine level ≥ 2mg/dL
• Development of myeloma bone lesions or soft tissue plasmacytoma

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=90 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=92 Participants Patients undergo observation until progression to symptomatic myeloma.
2-year Progression-free Survival (PFS) Rate (Phase III Primary Endpoint)	0.93 proportion of participants Interval 0.88 to 0.99	0.76 proportion of participants Interval 0.66 to 0.87

SECONDARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10

Population: All registered patients in the phase II part

Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR).

CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component < 100 mg per 24 hours

PR:

• ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
• If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels
• If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30%
• If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=44 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) Patients undergo observation until progression to symptomatic myeloma.
Proportion of Participants With Response (Phase II Secondary Endpoint)	0.477 proportion of participants Interval 0.325 to 0.633	—

SECONDARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry, every 6 months if patient is 2-5 years from study entry, then annually for years 6-10

Population: Among randomized patients who received treatment or observation

Response is defined as complete response (CR), very good partial response (VGPR) or partial response (PR).

CR: Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-component plus urine M-component < 100 mg per 24 hours

PR:

• ≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours
• If followed by free light chain (FLC) only, a ≥ 50% decrease in the difference between involved and uninvolved FLC levels
• If unmeasurable disease by serum M-protein, urine M-protein, and serum FLC at baseline, a ≥50% reduction in plasma cells provided baseline bone marrow percentage was ≥ 30%
• If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=88 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=86 Participants Patients undergo observation until progression to symptomatic myeloma.
Proportion of Participants With Response (Phase III Secondary Endpoint)	0.50 proportion of participants Interval 0.391 to 0.608	0 proportion of participants Interval 0.0 to 0.042

SECONDARY outcome

Timeframe: Assessed every 3 months for one year

Population: All randomized patients

PFS is defined as time from randomization to progression or death, whichever occurs first. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 1-year PFS rate.

1. Any of the following:

• Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression"
• Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression"
• Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)

2. Any of the following felt related to the underlying clonal plasma cell proliferative disorder:

• Hypercalcemia (> 11 mg/dL)
• Decrease in hemoglobin of ≥ 2 gms/dL
• Serum creatinine level ≥ 2mg/dL
• Development of myeloma bone lesions or soft tissue plasmacytoma

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=90 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=92 Participants Patients undergo observation until progression to symptomatic myeloma.
1-year Progression-free Survival (PFS) Rate (Phase III Secondary Endpoint)	0.98 proportion of participants Interval 0.95 to 1.0	0.89 proportion of participants Interval 0.82 to 0.96

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years

Population: All randomized patients in the phase III part of the study

TTP is defined as the time from randomization to progression. Patients are considered to have progression if both of the following criteria are met. Kaplan-Meier method was used to estimate 2-year progression-free rate.

1. Any of the following:

• Increase in serum M-protein to ≥ 25% above the lowest response level with an absolute increase of at least 0.5g/dl to qualify as "progression"
• Increase in urine M-protein to ≥ 25% above the lowest response level for 24-hour excretion with an absolute increase of at least 200mg/24 hours of urine M-protein to qualify as "progression"
• Increase in bone marrow plasma cell percentage to ≥ 25% from lowest response value (the absolute % increase must be ≥ 10%)

2. Any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder:

• Hypercalcemia (> 11 mg/dL)
• Decrease in hemoglobin of ≥ 2 gms/dL
• Serum creatinine level ≥ 2mg/dL
• Development of myeloma bone lesions or soft tissue plasmacytoma

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=90 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=92 Participants Patients undergo observation until progression to symptomatic myeloma.
2-year Progression-free Rate (Phase III Secondary Endpoint)	94.3 proportion of participants Interval 85.4 to 97.9	75.8 proportion of participants Interval 63.6 to 84.4

SECONDARY outcome

Timeframe: Assessed every 3 months for 2 years

Population: All randomized patients in the phase III part of the study

Overall survival is defined as the time from randomization to death or date last known alive among all randomized patients in the phase III part of the study. Kaplan-Meier method was used to estimate the 2-year OS rate.

Outcome measures

Measure	Arm A (Lenalidomide; Phase II) n=90 Participants Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=92 Participants Patients undergo observation until progression to symptomatic myeloma.
2-year Overall Survival (OS) Rate (Phase III Secondary Endpoint)	0.98 proportion of participants Interval 0.95 to 1.0	1.00 proportion of participants Interval 1.0 to 1.0

Adverse Events

Arm A (Lenalidomide; Phase II)

Serious events: 23 serious events

Other events: 14 other events

Deaths: 7 deaths

Arm A (Lenalidomide; Phase III)

Serious events: 40 serious events

Other events: 20 other events

Deaths: 2 deaths

Arm B (Observation; Phase III)

Serious events: 8 serious events

Other events: 5 other events

Deaths: 4 deaths

Serious adverse events

Measure	Arm A (Lenalidomide; Phase II) n=44 participants at risk Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Lenalidomide; Phase III) n=88 participants at risk Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=86 participants at risk Patients undergo observation until progression to symptomatic myeloma.
Psychiatric disorders Confusion	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Ear and labyrinth disorders Hearing impaired	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Ear and labyrinth disorders Vertigo	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Blood and lymphatic system disorders Blood and lymphatic disorders - Other	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Cardiac disorders Myocardial infarction	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Fatigue	11.4% 5/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.7% 5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Erythroderma	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Pruritus	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	4.5% 2/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Constipation	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Diarrhea	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	3.4% 3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Vomiting	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Gastrointestinal disorders - Other	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Hepatobiliary disorders Cholecystitis	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Immune system disorders Allergic reaction	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Infections and infestations Lung infection	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Infections and infestations Sepsis	4.5% 2/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Infections and infestations Skin infection	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Creatinine increased	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Lymphocyte count decreased	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Neutrophil count decreased	15.9% 7/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	13.6% 12/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Platelet count decreased	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Weight loss	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations White blood cell decreased	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Dehydration	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hypokalemia	4.5% 2/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Back pain	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Ataxia	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Dizziness	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Headache	4.5% 2/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Paresthesia	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Peripheral motor neuropathy	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Peripheral sensory neuropathy	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Syncope	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Nervous system disorders Nervous system disorders - Other	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Psychiatric disorders Insomnia	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	3.4% 3/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Renal and urinary disorders Acute kidney injury	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Renal and urinary disorders Chronic kidney disease	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Renal and urinary disorders Renal and urinary disorders - Other	2.3% 1/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Vascular disorders Hypertension	0.00% 0/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Vascular disorders Thromboembolic event	4.5% 2/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	0.00% 0/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

Other adverse events

Measure	Arm A (Lenalidomide; Phase II) n=44 participants at risk Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm A (Lenalidomide; Phase III) n=88 participants at risk Patients receive lenalidomide PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.	Arm B (Observation; Phase III) n=86 participants at risk Patients undergo observation until progression to symptomatic myeloma.
Blood and lymphatic system disorders Anemia	13.6% 6/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.7% 5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
General disorders Fatigue	9.1% 4/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	10.2% 9/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Gastrointestinal disorders Constipation	4.5% 2/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	8.0% 7/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Lymphocyte count decreased	6.8% 3/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	4.5% 4/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Neutrophil count decreased	11.4% 5/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	9.1% 8/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations Platelet count decreased	11.4% 5/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	5.7% 5/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Investigations White blood cell decreased	13.6% 6/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	10.2% 9/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	2.3% 2/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.
Skin and subcutaneous tissue disorders Rash maculo-papular	9.1% 4/44 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.1% 1/88 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.	1.2% 1/86 • Assessed every 4 weeks while on treatment and for 30 days after the end of treatment, up to 10 years Serious adverse events are defined as treatment-related adverse events of grade 3 or higher. Other adverse events are treatment-related adverse events not included in serious adverse events. Only patients who started protocol therapy are included in the analysis of adverse events. All registered patients are included in the analysis of all-cause mortality.

Additional Information

Study Statistician

ECOG-ACRIN Biostatistics Center

Phone: 617-632-3012

Email: eatrials@jimmy.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60